MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-29 for MICRO-VOLUME EXTENSION SET 2N3342 manufactured by Baxter Healthcare - Haina.
[134462649]
The single-use device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Leak testing and clear passage testing were performed with no issues noted. The device was found to flow normally with no defects or leaks observed. The reported condition was not verified. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[134462650]
This report summarizes
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1416980-2019-00366 |
| MDR Report Key | 8287444 |
| Date Received | 2019-01-29 |
| Date of Report | 2019-01-29 |
| Date Mfgr Received | 2018-12-31 |
| Date Added to Maude | 2019-01-29 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242702068 |
| Manufacturer G1 | BAXTER HEALTHCARE - DOMINICAN REPUBLIC |
| Manufacturer Street | CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO, PIISA |
| Manufacturer City | HAINA, SAN CRISTOBAL 91000 |
| Manufacturer Country | DR |
| Manufacturer Postal Code | 91000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MICRO-VOLUME EXTENSION SET |
| Generic Name | FILTER, INFUSION LINE |
| Product Code | FPB |
| Date Received | 2019-01-29 |
| Model Number | NA |
| Catalog Number | 2N3342 |
| Lot Number | DR18I06024 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAXTER HEALTHCARE - HAINA |
| Manufacturer Address | HAINA SAN CRISTOBAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-29 |